Using perineal massage during pregnancy to improve muscle relaxation
Does Perineal Massage in Pregnancy Reduce the Levator Ani Muscle Co-activation?
NA · Azienda Sanitaria Universitaria Friuli Centrale · NCT06296134
This study is testing if perineal massage during the third trimester of pregnancy can help women relax a specific muscle to improve childbirth outcomes compared to standard care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 58 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Azienda Sanitaria Universitaria Friuli Centrale (other) |
| Locations | 1 site (Udine) |
| Trial ID | NCT06296134 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of perineal massage in reducing levator ani muscle co-activation during the third trimester of pregnancy. Participants will be randomized into two groups: one group will perform self-administered perineal massage, while the other will receive standard care. The study will assess whether the massage can help the levator ani muscle relax instead of co-contracting during childbirth, potentially leading to better obstetric outcomes. The trial will involve screening women for specific eligibility criteria during their anatomical scan at 20-22 weeks of gestation.
Who should consider this trial
Good fit: Ideal candidates for this study are nulliparous pregnant women with a single fetus in cephalic presentation who are fluent in Italian.
Not a fit: Patients who are multiparous, have contraindications to vaginal delivery, or have a BMI of 30 or higher may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could lead to improved childbirth outcomes and reduced incidence of severe perineal trauma.
How similar studies have performed: While this approach is relatively novel, previous studies have indicated a correlation between levator ani muscle co-activation and adverse obstetric outcomes, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: pregnant women with the following characteristics: * nulliparous * single pregnancy * cephalic presentation of the fetus * Italian language fluency Exclusion Criteria: * multiparous * age \< 18 y, age \> 40 y * previous urinary or fecal incontinence * contraindications to vaginal delivery (such as placenta previa, vasa previa, etc) * twin pregnancy * language barrier * BMI at or \> 30
Where this trial is running
Udine
- Serena Xodo — Udine, Italy (RECRUITING)
Study contacts
- Study coordinator: Serena Xodo, M.D.
- Email: serena.xodo@gmail.com
- Phone: 0432-559699
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pelvic Floor Disorders, Levator Ani Syndrome